Method and apparatus for ocular microcurrent stimulation therapy

ABSTRACT

Devices and methods to deliver microcurrent stimulation therapy to the human body, when connected to a micro-stimulation current-generating apparatus. The method of applying microcurrent stimulation therapy to key points around the eye for treatment of problems such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis and other eye-related or nerve-related conditions, as well as other diseases, such as Bell&#39;s Palsy, requiring localized stimulation to the eyes and/or on other body parts.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation application of U.S. patent applicationSer. No. 15/759,515 filed Mar. 12, 2018 (which issues as U.S. Pat. No.10,391,312 on Aug. 27, 2019), which is a national-phase filing of, andclaims priority benefit of, PCT Patent Application No.PCT/US2016/051550, filed Sep. 13, 2016 by Blair P. Mowery et al. andtitled “Apparatus and method for ocular microcurrent stimulationtherapy,” which claims priority benefit, including under 35 U.S.C. §119(e), of U.S. Provisional Patent Application No. 62/283,870, filedSep. 15, 2015 by Mowery et al., titled “Appliance for microcurrentstimulation therapy using a disposable material afixed to the upper andlower eye lid & other body parts,”

U.S. Provisional Patent Application No. 62/283,871, filed Sep. 15, 2015by Masko et al., titled “Apparatus for a method of application ofmicrocurrent stimulation therapy, consisting of a goggle device affixedto & encircling the upper and/or lower eyelids, as well as other bodyparts,” andU.S. Provisional Patent Application No. 62/365,838, filed Jul. 22, 2016by Tapp et al., titled “Appliance for micro-current stimulation,” eachof which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to devices and methods to electricallystimulate animal tissue, and in particular to a microstimulationelectrode appliance that delivers microcurrent stimulation therapy tothe human body, when connected to a microstimulation current generatingapparatus. The present invention further relates to a way of applyingmicrocurrent stimulation therapy to key points around the eye fortreatment of diseases such as macular degeneration, retinitispigmentosa, glaucoma, optic neuritis, optic neuropathy, diabeticretinopathy, macular edema, papilledema, and other eye-related ornerve-related maladies, as well as other diseases, such as Bell's Palsy,requiring localized stimulation on other body parts.

BACKGROUND OF THE INVENTION

Chronic pain is a problem for millions of individuals throughout theworld. One method of treating such pain is to provide microcurrentstimulation around or near the areas where the pain is occurring.Microcurrent, which typically is defined as current below one (1)milliamp, can provide rapid and long-lasting pain relief for a widevariety of pain syndromes. Generally, microcurrent stimulation therapytypically includes applying a current in the range of about 20 to about300 microamps (˜20 to ˜300 μA) to the affected area. The current blocksneuronal transmission of pain signals and stimulates the release ofendorphins to help relieve the pain in chronic and acute pain patientsand suppress the inflammatory response.

In addition to chronic pain relief, microcurrent therapy is being usedto treat a number of visual diseases, including macular degeneration,retinitis pigmentosa, macular edema, glaucoma, optic neuritis, Bell'sPalsy and other diseases. It is believed, through secondary literature,that this microcurrent treatment stimulates blood flow, increases ATP(adenosine triphosphate) at the cellular level, and enhances cellularpermeability. Further, it is believed such stimulation can re-establishfunctional neural pathways for muscle and brain, as well as for bloodvessel and brain.

Age-related macular degeneration (AMD) is a very common eye disease,affecting more people than glaucoma. Macular degeneration is the mostfrequent cause of blindness for patients aged 60 and above in the UnitedStates, and is estimated to affect over 10 million Americans. (Source:National Health Institute). Macular degeneration results in thedeterioration of various retinal tissues in the region of the macula,the central, most sensitive light-sensing area of the retina responsiblefor detailed central vision. Impaired blood circulation in the centralretina, with partial to full corresponding vision loss, is a typicalconsequence of macular degeneration.

Because there is currently no approved treatment for dry AMD, littleresearch has been done on the market potential. There is, however,significant data on the large numbers of people affected by AMD, whichis estimated to cause about 8.7% of blindness and low vision globally.According to a report from the World Health Organization, “AMD is theprimary cause of blindness in the developed countries and the thirdleading cause worldwide.” The prevalence of AMD in Europe is estimatedto be: 16.3 million people (excluding southeastern and eastern Europe),and in the United States 10.2 million people. Further, this increases toa combined total of 41 million cases when adding in Canada, Australia,New Zealand, Russia, and Japan. Ninety percent (90%) of these cases aredry AMD for which there is no currently approved treatment to restorevision.

Approximately 25% of the population in the target markets (aged 65 to 75years old) has AMD, and this increases to 35% for ages 75 and older.Within the next 10 to 20 years, as “baby boomers” reach theirmid-sixties and older, the prevalence of the disease is projected todramatically increase. In a study funded by the U.S. Centers for DiseaseControl and Prevention, researchers reported that as many as 9.1 millionpeople in the U.S. had AMD in 2010 and 17.8 million would have it by2050 (Rein et al., “Forecasting age-related macular degeneration throughthe year 2050: the potential impact of new treatments,” Arch Ophthalmol.2009 April; 127(4):533-40. doi: 10.1001/archophthalmol.2009.58).

The U.S. spends $2.7 trillion in healthcare each year, of which eye carerepresents roughly three percent or $60-$70 billion of the total.According to Eurostat, the European Union (EU) spends 45.7% of thatamount or about $1.23 trillion. Expenditures for eye care are growing atsix percent annually. According to the National Institute for Health(NIH), it is expected to continue to grow at least six percent over thenext several decades, driven by the aging population.

Macular degeneration causes about $184 billion in lost productivity eachyear and approximately $51 billion is spent treating maculardegeneration each year in the United States. Ninety percent (90%) ofmacular degeneration cases are the “dry” or non-bleeding form, termed“atrophic AMD” and about 10% of cases are the “wet” or bleeding form,termed “exudative AMD”.

U.S. Pat. No. 7,158,834 issued to Paul, Jr. on Jan. 2, 2007 with thetitle “Method and apparatus for performing microcurrent stimulation(MSC) therapy,” and is incorporated herein by reference. U.S. Pat. No.7,158,834 describes a method and apparatus for providing microcurrentstimulation (MSC) therapy. U.S. Pat. No. 7,158,834 states: it has beendetermined that the application of microcurrent signals at particularfrequencies to the eye for particular periods of time stabilizes andeven improves conditions of macular degeneration and other oculardiseases.

U.S. Pat. No. 8,731,657 issued to Shambayati, et al. on May 20, 2014with the title “Multi-mode microcurrent stimulus system with safetycircuitry and related methods,” and is incorporated herein by reference.U.S. Pat. No. 8,731,657 describes a microcurrent stimulation device witha power supply, two or more electrodes electronically coupled to thepower supply, a microcontroller configured to generate anelectromagnetic waveform, an impedance measurement module configured tomeasure electrical impedance of one or more biological tissues betweenthe two or more electrodes. A first safety circuit monitors electriccurrent flow through one or more components of the microcurrentstimulation device and interrupts electric current flow if the electriccurrent flow through the one or more components is above a predeterminedlevel. A second safety circuit interrupts electric current flow throughthe one or more components if a firmware failure occurs.

U.S. Pat. No. 8,116,841 issued to Bly, et al. on Feb. 14, 2012 with thetitle “Adherent device with multiple physiological sensors,” and isincorporated herein by reference. U.S. Pat. No. 8,116,841 describes anadherent device to monitor a patient for an extended period comprises abreathable tape. The breathable tape comprises a porous material with anadhesive coating to adhere the breathable tape to a skin of the patient.At least one electrode is affixed to the breathable tape and capable ofelectrically coupling to a skin of the patient. A printed circuit boardis connected to the breathable tape to support the printed circuit boardwith the breathable tape when the tape is adhered to the patient.Electronic components electrically are connected to the printed circuitboard and coupled to the at least one electrode to measure physiologicsignals of the patient. A breathable cover and/or an electronics housingis disposed over the circuit board and electronic components andconnected to at least one of the electronics components, the printedcircuit board or the breathable tape.

U.S. Pat. No. 7,326,181 issued to Katims on Feb. 5, 2008 with the title“Nervous tissue stimulation device and method,” and is incorporatedherein by reference. U.S. Pat. No. 7,326,181 describes a method using aprecisely controlled, computer programmable stimulus for neuroselectivetissue stimulation that does not leave a sufficient voltage orelectrical artifact on the tissue being stimulated that would interfereor prevent a monitoring system from recording the physiological responseis utilized to evaluate the physiological conduction of the tissue beingstudied. A computer controls both the waveform, duration and intensityof the stimulus. An output trigger to the nerve response recordingcomponent controls the timing of its operation. A neuroselective nervoustissue response latency and amplitude may be determined. The computercontrolled stimulus may also be administered for therapeutic purposes.

U.S. Pat. No. 7,215,989 issued to Burks on May 8, 2007 with the title“Multiple electrode assembly,” and is incorporated herein by reference.U.S. Pat. No. 7,215,989 describes multiple electrode assemblies thatprovide an electrical connection between a patient's body and monitoringequipment. A multiple electrode assembly requires only half as manyassemblies as a conventional single electrode assembly to attach apatient to multiple pieces of equipment. Less time is required to attachthe patient to the monitoring equipment. There is less patientdiscomfort since fewer assemblies are attached to the patient. Theplacement of fewer assemblies also leads to a reduced cost. Theassemblies can take on a number of different shapes and lead attachmentconfigurations to accommodate a wide range of monitoring functions.

U.S. Pat. No. 7,062,319 issued to Ihme, et al. on Jun. 13, 2006 with thetitle “Method and arrangement for determining suitable treatmentfrequency and/or intensity,” and is incorporated herein by reference.U.S. Pat. No. 7,062,319 describes a method and arrangement fordetermining a suitable treatment frequency and/or intensity of atreatment signal used in electrical treatment. In the method, astimulating electrical signal is directed to an object to producedifferent reaction types in the object at different intensities of thestimulating electrical signal. For at least three different reactiontypes, the intensity of the stimulating electrical signal at which areaction type occurred is stored. The electrical signal intensitiesstored for the different reaction types at least at three differentfrequencies are compared with reference values and the frequency and/orsignal intensity at which the signal intensity deviates sufficientlyfrom one or more reference values is determined. The method utilizes thefrequency and/or signal intensity found in the process in determiningthe suitable treatment frequency and/or signal intensity.

U.S. Pat. No. 6,636,754 issued to B aura et al. on Oct. 21, 2003 withthe title “Apparatus and method for determining cardiac output in aliving subject,” and is incorporated herein by reference. U.S. Pat. No.6,636,754 describes an improved apparatus and method for determining thecardiac output of a living subject. Their improved apparatus generallycomprises one or more electrode assemblies or patches affixed to theskin of the subject in the vicinity of the thoracic cavity. Theterminals of each electrode patch are in contact with an electrolyticgel, and are spaced a predetermined distance from one another within thepatch. This predetermined spacing allows for more consistentmeasurements, and also allows for the detection of a loss of electricalcontinuity between the terminals of the patch and their associatedelectrical connectors in the clinical environment. The method generallycomprises generating and passing a stimulation current through theterminals and the thoracic cavity of the subject, and measuring theimpedance as a function of time. This impedance is used to determinecardiac muscle stroke volume, which is then used in conjunction with thesubject's cardiac rate (also detected via the electrode patches) todetermine cardiac output. A method of detecting a loss of electricalcontinuity in one or more of the terminals of the electrode patch isalso disclosed.

U.S. Pat. No. 6,035,236 issued to Jarding, et al. on Mar. 7, 2000 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy,” and is incorporated herein by reference. U.S. Pat. No.6,035,236 describes an apparatus for supplying an electrical signal to abody part in order to provide microcurrent stimulation therapy to thebody part. The apparatus preferably comprises a first sweep wave orsweep frequency signal generator configured to generate a first sweepwave signal, a buffer amplifier circuit configured to receive the firstsweep wave signal from the first sweep signal generator and amplify andbuffer the sweep wave signal creating a buffered sweep wave signal. Inaddition, the apparatus preferably includes a current limiting circuitconfigured to receive the buffered sweep wave signal from the bufferamplifier circuit and limit the amount of current supplied to the bodypart. Finally, the apparatus preferably comprises a probe for applyingthe sweep wave signal to the body part. The apparatus may furthercomprise a second signal generator for generating a second signal whichmay comprise either a sweep wave signal or a non-sweep wave signal. Theapparatus also will include a signal combining circuit configured toreceive the first and second signals from the first and second signalgenerators and combine the first and second signals into a compositesweep wave signal.

U.S. Pat. No. 6,275,735 issued to Jarding, et al. on Aug. 14, 2001 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy,” and is incorporated herein by reference. U.S. Pat. No.6,275,735 describes a method and apparatus for providing microcurrentstimulation therapy to a body part is disclosed. In one embodiment, amethod allows digital control of the modulation frequency of themicrocurrent signal. The method includes receiving a first digital dataword which is used to produce a first frequency related to the firstdigital data word, whereupon, a first microcurrent signal at the firstfrequency is applied to the body part. A second digital data word isreceived and used to produce a second frequency related to the seconddigital data word. A second microcurrent signal at the second frequencyis applied to the body part. In another embodiment, a method allowsdirect digital synthesis of the microcurrent stimulation signal. A firstdigital data word is used to produce a first analog voltage which isapplied to the body part. A second digital data word is used to producea second analog voltage which is also applied to the body part, wherethe first analog voltage is different from the second analog voltage. Inyet another embodiment, an apparatus for providing microcurrentstimulation therapy includes a digital-to-analog converter, a controllerand a plurality of data words. The controller is coupled to thedigital-to-analog converter and supplies the digital-to-analog converterwith digital data words in order to generate an electrical signal forthe microcurrent stimulation therapy.

U.S. Patent Publication 2005/0137649 by Paul, Jr. published on Jun. 23,2005 with the title “Method and apparatus for performing microcurrentstimulation (MSC) therapy,” and is incorporated herein by reference.Patent Publication 2005/0137649 describes a method and apparatus forproviding microcurrent stimulation (MSC) therapy, and asserted: it hasbeen determined that the application of microcurrent signals atparticular frequencies to the eye for particular periods of timestabilizes and even improves conditions of macular degeneration andother ocular diseases and that experimental data from clinical trialsshows that results of persons who underwent therapy are at least betterthan placebo, and that the therapy is safe and efficacious. PatentPublication 2005/0137649 continued: experimental data from clinicaltrials showed that approximately 98% of the patients who underwent theMCS therapy of the invention experienced either stabilization orimprovement of macular degeneration within one year of starting therapy.Of this percentage, approximately 65% of the patients subjected to theMCS therapy experienced improved vision, while approximately 32%experienced stabilization of macular degeneration (i.e., no further lossof vision).

U.S. Patent Publication 2008/0171929 by Katims published on Jul. 17,2008 with the title “Method for standardizing spacing betweenelectrodes, and medical tape electrodes,” and is incorporated herein byreference. Patent Publication 2008/0171929 describes Standardizationbetween paired electrodes is maintained in a medical device withoutneeding a Mylar spreader, such as by forming the paired electrodesintegrally with a tape part.

U.S. Pat. No. 4,018,218 to Carlson et al. issued on Apr. 19, 1977 withthe title “Method and apparatus for sleep induction,” and isincorporated herein by reference. U.S. Pat. No. 4,018,218 describes anapparatus and method to induce sleep in a patient that utilizes anoscillator to control the frequency of electric impulses received by thepatient. First and second multivibrators generate the signals necessaryto stimulate the central nervous system by conduction through the opticnerve tract, and also to generate a visual aura caused by stimulation ofthe retina of the eye. An amplifier amplifies the signals generated bythe multivibrators and electrodes transmit the amplified signal to thepatient. The various components of the apparatus may be stored in an eyeframe structure wherein eye lid electrode pads are held in placecontiguous the eyes of the patient, and wherein mastoid electrode padsare held in place by means of the frame ear hooks.

U.S. Pat. No. 5,522,864 to Wallace et al. issued on Jun. 4, 1996 withthe title “Apparatus and method for ocular treatment,” and isincorporated herein by reference. U.S. Pat. No. 5,522,864 describes thatmacular degeneration and other ocular pathology in a subject are treatedby the steps of: placing a positive electrode of a direct current sourcein electrical contact with a closed eyelid of a subject; placing anegative electrode of the source in electrical contact with theposterior neck of the subject; and causing a constant direct current of200 μA to flow between the electrodes through the subject for about 10minutes. The source can be a portable, battery powered constant directcurrent generator which is affixed to the subject. The subject canambulate during treatment.

U.S. Pat. No. 6,445,955 to Michelson et al. issued on Sep. 3, 2002 withthe title “Miniature wireless transcutaneous electrical neuro ormuscular-stimulation unit,” and is incorporated herein by reference.U.S. Pat. No. 6,445,955 describes a miniature wireless transcutaneouselectrical neuro or muscular stimulation unit. The unit has a housingattached to a plurality of electrodes. An electronics module containingan electrical circuit is contained within the housing and provides asequence of monophasic or biphasic pulses to a patient's pain site viathe electrodes. The electrodes can be disposable and come in a varietyof shapes and sizes. The patient may select and control the intensityand the frequency of the pulses by choosing one of several TENS andmicrocurrent waveforms, as well as the orientation and quantity of theelectrodes. The means for supplying power to the electronics module canbe integrated with the electrodes in one detachable and disposableassembly. A worn-remote controller can send transmission signals to areceiver within the electronic module thereby allowing the patient toprogram specific units placed on the patient's body to performoperations in a specified series of waveforms. The electrodes may beembedded in a splint, bandage, brace or cast, where wires orflex-circuit material connect the electrodes to the unit. The electrodescan be arranged in a grid-like manner to allow for programming of aspecific firing order which provides for greater therapeutic effect to apain site, and may also be embedded in adhesive strips, similar to aconventional Band-Aid.

What is still needed is an improved method and apparatus for treatingcertain eye problems.

SUMMARY OF THE INVENTION

In some embodiments, the present invention provides an apparatus thatincludes: a disposable therapy appliance, wherein the disposable therapyappliance includes: a strip of material containing a plurality ofelectrodes configured to apply microcurrent stimulation therapy to apatient, wherein each electrode is no larger than 50 mm² (e.g., eachelectrode sized as a square about 7 mm by 7 mm, or a circle having adiameter of about 8 mm), and wherein the strip is shaped to bepositioned to place electrodes on an upper eyelid and a lower eyelid ofa the patient's skin, and wherein each one of the plurality ofelectrodes is configured to be individually activated at a time formicrocurrent stimulation without activation of any other ones of theplurality of electrodes during that time. In other embodiments, eachelectrode is no larger than 36 mm² (e.g., each electrode sized as asquare no larger than about 6 mm by 6 mm, or a circle having a diameterof no larger than about 6.75 mm). In other embodiments, each electrodeis no larger than 25 mm² (e.g., each electrode sized as a square nolarger than about 5 mm by 5 mm, or a circle having a diameter of nolarger than about 5.6 mm).

In some embodiments, the present invention applies microcurrentstimulation therapy to key points around the eye (and/or other bodyparts) for treatment of diseases such as macular degeneration, retinitispigmentosa, glaucoma, optic neuritis, optic neuropathy, diabeticretinopathy, macular edema, papilledema, and other eye or nerve related,as well as other diseases, such as Bell's Palsy, requiring localizedstimulation on other body parts.

In some embodiments of the apparatus, the strip of material includes anadhesive suitable to adhere the strip adhere to the skin.

In some embodiments of the apparatus, the strip of material includes anadhesive suitable to adhere the strip to a goggle device; and theapparatus further includes the goggle device, wherein the goggle deviceis shaped to hold the plurality of electrodes against the patient's skinwithout any adhesive touching the patient's skin. In some suchembodiments, the apparatus further includes a vibrator connected to thegoggle device to convey a gentle level of vibration as the microcurrentstimulation therapy is being applied.

In some embodiments, the present invention provides a method thatincludes: providing a disposable strip of material containing aplurality of electrodes configured to apply microcurrent stimulationtherapy to a patient, wherein each electrode is no larger than 50 mm²,and wherein the strip is shaped to be positioned to place electrodes onan upper eyelid and a lower eyelid of the patient's skin, wherein theelectrodes are spaced at predetermined location points along the stripof material, and wherein each one of the plurality of electrodes isconfigured to be individually activated at a time for microcurrentstimulation without activation of any other ones of the plurality ofelectrodes during that time; providing a microcurrent-stimulationcontroller, wherein the electrodes are wired individually and separatelyto the microcurrent-stimulation controller; applying the disposablestrip of material to the patient's skin; generating prescribedmicrocurrent pulses by the microcurrent-stimulation controller; anddelivering the microcurrent pulses to each respective electrode of theplurality of electrodes in a temporal sequence.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic front-view diagram of a disposable eye-therapyappliance strip system 101 having four disposable curved linear adhesivetherapy strips 115 positioned on the upper and lower eyelids of a person99, showing exemplary positions of electrodes and connections totreatment apparatus, according to some embodiments of the presentinvention.

FIG. 1B is a front view of a system 102 showing an eye having twodisposable adhesive therapy strips 115, one each positioned on the upperand lower eyelid of a person's eye 98, showing exemplary position ofelectrodes and connections to a micro-current stimulation controllerapparatus 161, according to some embodiments of the present invention.

FIG. 1C is a side cross-section view a disposable adhesive therapy strip115, according to some embodiments of the present invention.

FIG. 1D is a schematic enlarged cross-section view a disposable adhesivetherapy strip subsystem 140 including peel-away cover 116, according tosome embodiments of the present invention.

FIG. 1E is a schematic enlarged cross-section view a disposable adhesivetherapy strip 145 without peel-away cover 116, according to someembodiments of the present invention.

FIG. 1F is a schematic enlarged front view a disposable adhesive therapystrip subsystem 140, according to some embodiments of the presentinvention.

FIG. 1G is a schematic enlarged cross-section view a disposable adhesivetherapy strip subsystem 160, according to some embodiments of thepresent invention.

FIG. 2A is a schematic front-view diagram of a disposable partiallyencircling eye-therapy appliance strip system 201, using two singleadhesive therapy strips 215 with electrodes for both upper and lower eyelid showing position of electrodes and cable to micro-currentstimulation controller apparatus, according to some embodiments of thepresent invention.

FIG. 2B is an enhanced detail view of a system 202 on the upper andlower eyelid around a patient's eye 98 of disposable partiallyencircling eye therapy-appliance strip 215 positioned on the upper andlower eye lid showing position of electrodes and connections tomicro-current stimulation controller apparatus, according to someembodiments of the present invention.

FIG. 2C is a side cross-section view of a disposable partiallyencircling therapy-appliance strip 265, according to some embodiments ofthe present invention.

FIG. 3A is a schematic front-view diagram of two single encircling stripdisposable therapy strips 310 forming a system 301, according to someembodiments of the present invention.

FIG. 3B is an enhanced detail view of a system 302 on the upper andlower eyelid around a patient's eye 98 of disposable eye-encirclingtherapy strip 310 positioned on the upper and lower eye lid showingposition of electrodes and connections to micro-current stimulationcontroller apparatus, according to some embodiments of the presentinvention.

FIG. 3C is a side cross-section view a disposable therapy strip 365,according to some embodiments of the present invention.

FIG. 4A is a schematic back-side-view diagram of an eye-glass-frame 401having two encircling strips 410, according to some embodiments of thepresent invention.

FIG. 4B is a schematic back-side-view diagram of an eye-goggle-frame 402having two face-conforming encircling strips 412, according to someembodiments of the present invention.

FIG. 4C is a schematic top-side-view diagram of eye-goggle-frame 402having two face-conforming encircling strips 412, according to someembodiments of the present invention.

FIG. 5A is a schematic exploded top-side-view diagram 560 of aneye-goggle-frame 560 having two yet-to-be-attached disposable adhesiveeye encircling strips 511, according to some embodiments of the presentinvention.

FIG. 5B is a schematic assembled top-side-view diagram ofeye-goggle-frame 561 having two attached disposable adhesive eyeencircling strips 515, according to some embodiments of the presentinvention.

FIG. 6A is a schematic front-view diagram of two single semi-encirclingstrip disposable therapy strips 615 forming a system 601, according tosome embodiments of the present invention.

FIG. 6B is a plan-view diagram of a disposable set 660 of electrodesincluding a single semi-encircling strip disposable therapy strip 615and a single “ground” electrode 641, according to some embodiments ofthe present invention.

FIG. 7 is a schematic block diagram of a therapy system 700 including acontroller 701 and electrodes 715, according to some embodiments of thepresent invention.

FIG. 8 is a schematic block diagram of a therapy system 800 including acontroller 161 and light sensors 811, according to some embodiments ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

Although the following detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the invention. Specific examples are used toillustrate particular embodiments; however, the invention described inthe claims is not intended to be limited to only these examples, butrather includes the full scope of the attached claims. Accordingly, thefollowing preferred embodiments of the invention are set forth withoutany loss of generality to, and without imposing limitations upon theclaimed invention. Further, in the following detailed description of thepreferred embodiments, reference is made to the accompanying drawingsthat form a part hereof, and in which are shown by way of illustrationspecific embodiments in which the invention may be practiced. It isunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the present invention.

It is specifically contemplated that the present invention includesembodiments having combinations and sub-combinations of the variousembodiments and features that are individually described herein (i.e.,rather than listing every combinatorial of the elements, thisspecification includes descriptions of representative embodiments andcontemplates embodiments that include some of the features from oneembodiment combined with some of the features of another embodiment,including embodiments that include some of the features from oneembodiment combined with some of the features of embodiments describedin the patents and application publications incorporated by reference inthe present application). Further, some embodiments include fewer thanall the components described as part of any one of the embodimentsdescribed herein.

The leading digit(s) of reference numbers appearing in the Figuresgenerally corresponds to the Figure number in which that component isfirst introduced, such that the same reference number is used throughoutto refer to an identical component which appears in multiple Figures.Signals and connections may be referred to by the same reference numberor label, and the actual meaning will be clear from its use in thecontext of the description.

Causes of AMD and Potential Treatment

Normal retinal cell function is a photochemical reaction convertinglight energy to an electrical impulse which travels to the brain andvision occurs. With AMD and other visual system diseases, diseased andinflamed retinal cells eventually lose cell function. Adenosinetriphosphate (ATP) levels drop, protein synthesis drops, the electricalresistance goes up, and cell membrane electrical potential goes downlimiting a cell's ability to move substrates into and out of a cell. Thecells, without normal metabolic activity, go temporarily dormant for atime before prior to apoptosis.

It is believed that, when electrical stimulation is provided to thecells before they die, blood vessel permeability is increased, normalcellular electrical potential is reestablished or achieved, the ATPlevels increase, protein synthesis will occur again, immature cellregeneration is activated, and normal cell metabolism is restoredthereby improving or restoring vision function. In addition, in vitrostudies have demonstrated that electrical stimulation appears to have ahealing effect on the small blood vessels in the retina, promoting amore efficient delivery of nutrients to the retinal cells and a moreefficient elimination of metabolic by-products.

The retinal pigment epithelium (RPE) is the support cell complex for thephotosensitive rod and cone cells which make up the light-sensingstructure of the retina. The RPE is the first to be affected bycirculation impairment. Once affected by poor circulation, the RPEcannot efficiently assist the rods and cones in removing the metabolicand photochemical response by-products, which are essential for cellularfunction. Yellowish-colored sub-retinal deposits called “drusen” formwhen extracellular by-products are not carried away by blood circulatingthrough the eye. As a result, the photoreceptor cells in the macula loseaccess to good blood flow and enter a dormant, toxic state and do notrespond to light. If normal retinal cellular metabolism is not restored,the cells die and visual acuity is permanently lost. Thus, it isbelieved that micro-current stimulation will help rejuvenate the cellsin the retina to slow or stop degeneration and in many cases triggerregeneration of retinal cells of the eye due to AMD.

While microcurrent stimulation therapy has been used to treat AMD andother visual system diseases, the methods and apparatus used in theprior art do not appear to maximize the therapeutic effect. Clinicalstudies have demonstrated that with the proper microcurrent stimulationwaveform and therapy procedure, AMD may be slowed or stopped in a largenumber of people suffering from the disease, and in some patient groupsvision can be restored. However, the efficacy of these therapies can beaffected by the manual techniques medical professionals use toadminister the therapy, or by the inefficient design and function of themedical device. When patients have significant skin impedance, or wherethere is a poor electrical conductivity, uptake of the stimulation levelis limited and this may limit the treatment efficacy.

In some embodiments, the present invention includes a disposableadhesive therapy appliance that replaces the need for long manualapplications of the microcurrent electrostimulation therapy currentlyused or being envisioned as used by a clinical professional.Furthermore, the present invention also enables the clinician orphysician to deliver stimulation to a particular designated point on thebody, as opposed to a broader coverage or blanketed area of the body.Conventional technologies have two major drawbacks. First, whenstimulation is delivered with a conventional probe or pointer, the probeor pointer is applied to the patient's skin manually and this takes alarge amount of clinician time to administer the stimulation andproperly deliver it. Secondly, when conventional gel strip orsemi-circle or circles are used in any kind of electrostimulation ormicrocurrent therapy, the conventional gel strip or semi-circle orcircles cover and deliver stimulation affecting a broad part of thehuman body, usually well in excess of 20 millimeters across. Theseconventional gel strips, semi-circles or circles do not permit thedelivery of stimulation to a “pinpointed” area of two-to-fifteen (2-15)millimeters diameter. In contrast, the present invention allows forstimulation to a sequence of such “pinpointed” areas, and the presentinvention can, in certain treatment therapies, be more efficacious dueto a greater stimulation level delivered on a smaller surface area,which penetrates more deeply and improves treatment performance.

FIG. 1A is a schematic front-view diagram of a disposabletherapy-appliance strip system 101 having four disposable adhesivecurved linear therapy strips 115 positioned on the upper and lowereyelids of the left and right eyes of a person 99, showing exemplarypositions of electrodes 111 and connections to treatment-controlapparatus 190, according to some embodiments of the present invention.In some embodiments, for each disposable adhesive curved linear therapystrips 115, each electrode 111 of a plurality of individuallyactivatable electrodes 111 is coated with an electrically conductive geland surrounded by an electrically insulating adhesive, in order thatwhen an electrical signal is applied to a first selected electrode 111,the current goes into the tissue of the patient 99 only under that firstelectrode (and, in some embodiments, one or more other electrodes 111)when the signal from treatment-control apparatus 190 is active to thefirst electrode (and the one or more other electrodes 111 if thoseelectrodes are also driven at that time). In some embodiments, the areaof tissue under each one of a plurality of electrodes is between about 1mm² and about 50 mm² (e.g., each electrode having electrical contact toskin in a square of about 1 mm by 1 mm to a square of about 7 mm by 7mm, or a circle having a diameter of about 1.125 mm to about 8 mm). Insome embodiments, each of a plurality of the electrodes 111 indisposable adhesive curved linear therapy strip 115 has a skin-contactarea of about 1 mm² (e.g., a square of 1 mm by 1 mm or other suitableshape with that area). In some embodiments, each of a plurality of theelectrodes 111 in disposable adhesive curved linear therapy strip 115has a skin-contact area of about 0.75 mm² (e.g., a square of 0.866 mm by0.866 mm, or a circle having a diameter of about 1 mm, or other suitableshape with that area). Some other embodiments include a plurality of theelectrodes 111 in disposable adhesive curved linear therapy strip 115wherein each electrode has a skin-contact area of between about 1 mm²and about 4 mm², a plurality of the electrodes 111 in disposableadhesive curved linear therapy strip 115 wherein each electrode has askin-contact area of about 4 mm², a plurality of the electrodes 111 indisposable adhesive curved linear therapy strip 115 wherein eachelectrode has a skin-contact area of between about 4 mm² and about 9mm², a plurality of the electrodes 111 in disposable adhesive curvedlinear therapy strip 115 wherein each electrode has a skin-contact areaof about 9 mm², a plurality of the electrodes 111 in disposable adhesivecurved linear therapy strip 115 wherein each electrode has askin-contact area of between about 9 mm² and about 16 mm², a pluralityof the electrodes 111 in disposable adhesive curved linear therapy strip115 wherein each electrode has a skin-contact area of about 16 mm²,and/or a plurality of the electrodes 111 in disposable adhesive curvedlinear therapy strip 115 wherein each electrode has a skin-contact areaof between about 16 mm² and about 25 mm² (e.g., a square of 5 mm by 5 mmor other suitable shape with that area). In some other embodiments, eachof a plurality of the electrodes 111 in disposable adhesive curvedlinear therapy strip 115 is substantially circular with a diameter ofabout 1 mm (a skin-contact area of about 0.8 mm²), while some otherembodiments include a plurality of substantially circular electrodes 111each having a diameter of about 1.28 mm (a skin-contact area of about 1mm²), a plurality of substantially circular electrodes 111 each having adiameter of about 2 mm (a skin-contact area of about 3 mm²), a pluralityof substantially circular electrodes 111 each having a diameter of about3 mm (a skin-contact area of about 7 mm²), a plurality of substantiallycircular electrodes 111 each having a diameter of about 4 mm (askin-contact area of about 13 mm²), a plurality of substantiallycircular electrodes 111 each having a diameter of about 5 mm (askin-contact area of about 20 mm²), and/or a plurality of substantiallycircular electrodes 111 each having a diameter of about 6 mm (askin-contact area of about 28 mm²). In some embodiments, each electrodeis no larger than 50 mm² (e.g., each electrode sized as a square about 7mm by 7 mm, or a circle having a diameter of about 8 mm) and wherein thestrip is shaped to be positioned to place electrodes on an upper eyelidand a lower eyelid of a the patient's skin, and wherein each one of theplurality of electrodes is configured to be individually activated at atime for microcurrent stimulation without activation of any other onesof the plurality of electrodes during that time. In some embodiments,each electrode is between about 36 mm² and about 50 mm². In otherembodiments, each electrode is no larger than 36 mm² (e.g., eachelectrode sized as a square no larger than about 6 mm by 6 mm, or acircle having a diameter of no larger than about 6.75 mm). In someembodiments, each electrode is between about 25 mm² and about 36 mm². Inother embodiments, each electrode is no larger than 25 mm² (e.g., eachelectrode sized as a square no larger than about 5 mm by 5 mm, or acircle having a diameter of no larger than about 5.6 mm).

In some embodiments, each disposable therapy-appliance strip 115includes electrical conductors 114 electrically coupled totreatment-control apparatus 190. In some embodiments, treatment-controlapparatus 190 is located locally (e.g., in a battery operated unit thatis carried by person 99, such as in a shirt pocket or head-mountedelastic band), while in other embodiments, treatment-control apparatus190 is attached to or part of a computer-controlled apparatus such as alaptop personal computer, a tablet computer, a desktop computer or thelike. Therapy signals from the signal source 190 are carried by theconnection wire bundle 114 to electrodes 111, which deliver the currentload to the patient's tissue.

FIG. 1B is a front view of a system 102 showing one eye having twodisposable therapy-appliance strips 115, one each positioned on theupper and lower eyelid of a person's eye 98, showing exemplary positionof electrodes and connections to a micro-current stimulation controllerapparatus 161, according to some embodiments of the present invention.In some embodiments, micro-current stimulation controller apparatus 161includes a microprocessor (μP) operated by a battery, and optionally iscontrolled and/or programmed by a nearby laptop personal computer, atablet computer, a desktop computer or the like. In some embodiments,each disposable therapy-appliance strip 115 includes electricalconductors 114 electrically coupled to an electrical connector 117 thatplugs into or otherwise electrically connects to a correspondingconnector 162 on controller apparatus 161.

FIG. 1C is a side cross-section view of a disposable therapy-appliancestrip 115, according to some embodiments of the present invention. Asnoted above, in some embodiments, each one of a plurality ofindividually activatable electrodes 111 is coated with an electricallyconductive gel and surrounded by an electrically insulating adhesive, inorder that when an electrical signal is applied only to a first selectedelectrode 111, the current goes into the tissue of the patient 99 onlyunder that first electrode. In some embodiments, only one selectedelectrode 111 is activated (driven by a pulsed electrical signal) at anyone time, and each of a plurality of the electrodes 111 is sequentiallydriven by temporally separated pulses. In some embodiments, two or moreof a plurality of the electrodes 111 are driven by simultaneous pulsesor by pulses that at least partially overlap in time. In someembodiments, each one or a plurality of subsets of the electrodes istested to determine which are most effective at relieving symptomsand/or which, when driven by pulsed signals, may cause a worsening ofsymptoms. Based on the empirical results of such testing of subsets ofthe electrodes, the system (e.g., system 102 of FIG. 1B) selectivelyactivates those set(s) of electrodes 111 and the sequences of pulsesthat have been determined empirically to be effective and avoidsactivation of those set(s) of electrodes 111 and the sequences of pulsesthat have been determined empirically to worsen symptoms. The connectionwire bundle (e.g., a cable having a plurality of electrical conductors)114 is shown leading to the strip substrate 112 containing theelectrodes 111.

FIG. 1D is a schematic enlarged cross-section view of a disposabletherapy-appliance strip subsystem 140 including therapy-appliance strip145 and peel-away cover 116, according to some embodiments of thepresent invention. In some embodiments, disposable therapy-appliancestrip 145 includes electrodes 111 that are equivalent to those indisposable therapy-appliance strip 115 described above, however,disposable therapy-appliance strip subsystem 140 further includes one ormore light emitting features 122 (such as light-emitting diodes (LEDs)mounted in or on disposable therapy-appliance strip 145, orlight-conducting optical fibers connected to LEDs in micro-currentstimulation controller apparatus 161 or treatment-control apparatus 190described above) and/or one or more vibration units 121. In someembodiments, light emitting features 122 are activated to emit lightpulses at the same time that electrical treatment signals are applied toone or more electrodes 111 to provide feedback to patient 99 and/or tothe medical care professional who is monitoring the procedure, in orderto provide to them feedback to indicate that the procedure is inprocess. In some embodiments, vibration units 121 are activated togently vibrate the eyelids of patient 99 at the same time thatelectrical treatment signals are applied to one or more electrodes 111to provide feedback to patient 99, in order to provide to them feedbackto indicate that the procedure is in process. In some embodiments,therapy-appliance strip subsystem 140 includes the optional addition ofone or more motors 121 and/or one or more LEDs 122 for feedback. In someembodiments, the LED(s) provide a visually perceivable indication of thefunctioning operation of therapy strip 145 as feedback to patient 99and/or to the medical professional supervising the treatment that thedevice is functioning and/or an indication of which therapy protocol(e.g., one of a plurality of selectable protocols) is being appliedand/or an indication of how much time is remaining in the presentsession (or how much time has elapsed since the start of the presentsession). In some embodiments, the one or more motors 121 drive anoff-balance shaft that provides a tactile vibration to the patient'seyelid). In some embodiments, the light emitter(s) 122 on the stripindicates, via a single light or multiple lights, what the apparatusstatus is: off, in-treatment, intermittent connections, inappropriateelectrical impedance, and/or insufficient stimulation, and/or progressstatus of therapy (e.g., whether the session is ¼, ½, ¾, or ⅞ finished).In some embodiments, the light from LED(s) 122 is made to be visiblethrough the patient's closed eyes to indicate that the therapy sessionis “in treatment and working,” or whether the session is finished. Insome embodiments, the light emission from LED(s) 122 is also visibleexternally so that the clinician can assess the status of the treatmenttherapy in session on a patient-by-patient basis without referring to adisplay screen on base station 790. In some embodiments, the applicationof an amount of microcurrent into one of the electrodes (e.g., in someembodiments, about 200 microamps or more may cause some patients toperceive a microcurrent-caused flash of light and/or a sensation ofvibration) from the microcurrent applied into and around the eye, evenin the absence of LED light emission from LEDs 122, and thus theemission of light from the LED(s) 122, and/or the vibration from motors121, can be used to mask from the patient whether or not microcurrentpulses were applied through one of the electrodes 111. For the purposesof testing the efficacy (wherein efficacy can be defined as theperformance of a therapy under ideal and controlled circumstances)and/or effectiveness (wherein effectiveness refers to the therapy'sperformance under “real-world” conditions) of the pulsed microcurrenttherapy of the present invention, it can be useful to supply a subset ofpatients with actual therapy along with light from the LED(s) 122,and/or vibration from motors 121 while presenting a different subset ofpatients with sham or placebo therapy with the difference (between theactual and sham sessions) masked, from the patient as well as from themedical professional supervising the treatment by light from the LED(s)122, and/or vibration from motors 121 (i.e., using double-blindexperiments). In some embodiments, the conductive gel 118 on eachelectrode 111 is kept moist and separated from the gel 118 on otherelectrodes 111 by cover 116 until therapy-appliance strip 140 isprepared for use by removing cover 116, thus exposing the gel 118.

FIG. 1E is a schematic enlarged cross-section view of a disposabletherapy strip 145, (i.e., disposable therapy-appliance strip subsystem140 with the peel-away cover 116 having been removed) connected to amicro-current stimulation controller apparatus 161 to form therapysystem 146, according to some embodiments of the present invention. Thistherapy system 146, in contrast to just therapy-appliance strip 145 oftherapy-appliance strip subsystem 140, includes the addition of themicro-current stimulation controller apparatus 161 connected by signalcable 114, wherein controller 161 drives the light signal 131, whichgoes toward the operator, and light signal 132, which goes toward thepatient 99 (e.g., in some embodiments, through the patient's eyelid).

FIG. 1F is a schematic enlarged front view of a disposable therapysystem 146, according to some embodiments of the present invention. Asnoted above, one or more light emitting features 122 and/or one or morevibration units 121 are provided in each disposable therapy-appliancestrip 145. In some embodiments, one LED 122 is provided for eachelectrode 111 and each LED 122 is activated at the same time as thecorresponding electrode 111. In some embodiments, each LED 122 islocated adjacent to, or directly above or below, the correspondingelectrode 111. This view of the device 140 also shows the connector 117for the wire bundle 114.

FIG. 1G is a schematic enlarged cross-section view of a disposabletherapy-appliance strip subsystem 160 including therapy-appliance strip165 and, according to some embodiments of the present invention. In someembodiments, disposable therapy-appliance strip subsystem 160 is asingle-use product that includes a built-in microprocessor-and-batteryunit 161 in the disposable therapy-appliance strip subsystem 160. Insome embodiments, the battery in unit 161 is air-activated via vent 163and removal of the protective air-barrier peel-away cover 116 activatesthe battery by letting air into vent 163. In some embodiments, anauxiliary disposable therapy-appliance strip 145 (i.e., a strip withoutthe built-in microprocessor-and-battery unit 161 that is applied to oneeyelid) can be connected to an activated disposable therapy-appliancestrip 160 attached to the other eyelid such that the singlemicroprocessor-and-battery unit 161 controls operation (sends treatmentsignals to, and receives feedback signals from, the electrodes 111, LEDs122, and/or vibration units 121) in both disposable therapy-appliancestrip 165 and the connected disposable therapy-appliance strip 145. Insome embodiments, the micro-current stimulation controller apparatus 161is attached to (and is part of) the strip 112, with an air vent 163 thatpasses through substrate 112 to allow air to contact and activate thebattery in controller apparatus 161. In some embodiments, controllerapparatus 161 is actively controlled wirelessly, during operation (e.g.,using protocol and circuitry such as Bluetooth®, near-fieldcommunications (NFC), or the like) from a nearby computer (such as atablet, desktop or laptop), while in other embodiments, controllerapparatus 161 is similarly wirelessly programmed before operation, andthereafter operates autonomously based on the program. In some suchembodiments, controller apparatus 161 transmits, back to the nearbycomputer, sensed signals that are then used to determine therapyefficaciousness and/or to control the therapy stimulation signals. Insome embodiments, the sensed signals transmitted to the nearby computerinclude sensed electrical impedance measurements for safety monitoringand control, and/or sensed nerve electrical signals, sensed from thepatient's skin, that might indicate patient discomfort or pain and thatare then used to limit the stimulation signals that would cause such areaction in the patient. In some embodiments, one or more of theelectrodes 111 that are not at the time being used to deliver therapystimulation signals are instead used to sense nerve electrical signalsfrom the patient's eyelid, and to deliver the sensed signals to anattached controller apparatus.

FIG. 2C and FIG. 3C are described below.

FIG. 2A is a schematic front-view diagram of a disposable appliancepartially encircling eye strip system 201, using, on each eye, a singlepartially encircling eye strip 215 with electrodes for both upper andlower eye lid showing position of electrodes 111 and cable 114 to amicro-current stimulation controller apparatus (not shown here—see FIG.1A for an example), according to some embodiments of the presentinvention. In some embodiments, a single partially encircling eye strip215 is functionally the same as a pair of curved linear therapy strip115 as described for FIG. 1A, however single partially encircling eyestrip 215 provides the advantage that the upper-lid portion and thelower-lid portion are automatically aligned relative to one another, andthe connections to the current stimulation controller apparatus issimpler. The various reference numbers in FIG. 2A are as described abovefor FIG. 1A.

FIG. 2B is an enhanced detail view on eye of disposable appliancepartially encircling eye strip 215 positioned on the upper and lowereyelid showing position of electrodes and connections to micro-currentstimulation controller apparatus, according to some embodiments of thepresent invention. In some embodiments, the single connector 217 shownhere replaces the two connectors 117 of FIG. 1B. The other variousreference numbers in FIG. 2B are as described above for FIG. 1B.

FIG. 2C is a side cross-section view of a disposable partiallyencircling therapy-appliance strip 265, according to some embodiments ofthe present invention, including a micro-current stimulation controllerapparatus 161 on the strip 265. The other various reference numbers inFIG. 2C are as described above for FIG. 1G.

FIG. 3A is a schematic front-view diagram of two single encircling stripdisposable therapy strips 315 forming a system 301, according to someembodiments of the present invention. In some embodiments, each of thedisposable therapy strips 315 is functionally the same as a pair ofcurved linear therapy strip 115 as described for FIG. 1A, or a singlepartially encircling eye strip 215, but each of the disposable therapystrips 315 provides the advantage that the upper-lid portion and thelower-lid portion are automatically aligned relative to one another atboth ends. The various reference numbers in FIG. 3A are as describedabove for FIG. 2A.

FIG. 3B is an enhanced detail view on eye of disposable eye-encirclingtherapy strip 315 positioned on the upper and lower eye lid showingposition of electrodes and connections to micro-current stimulationcontroller apparatus, according to some embodiments of the presentinvention. In some embodiments, the single connector 317 shown herereplaces the two connectors 117 of FIG. 1B. The other various referencenumbers in FIG. 3B are as described above for FIG. 1B.

FIG. 3C is a side cross-section view of a disposable therapy strip 365,according to some embodiments of the present invention, including amicro-current stimulation controller apparatus 161 included on the strip365. The other various reference numbers in FIG. 3C are as describedabove for FIG. 1G.

FIG. 4A is a schematic back-side-view diagram of an electrode-containingeye-glass-frame 401 having two encircling frame members 410 each havinga plurality of electrodes 111 positioned on strips on the periphery ofeach frame member 410, according to some embodiments of the presentinvention. In some embodiments, eye-glass-frame 401 includes mechanicalconnectors 421 and 422 on the temple tips of elastic side members 420that provide an adjustable-length holding mechanism to snugly hold framemembers 410 against the orbital bone and/or eyelids of the patient, anda stretchy (elastic) bridge 414 that provides an adjustable inter-oculardistance between the left and right eye of the patient. In someembodiments, each one of a plurality of conductors in cable 114 iselectrically connected to a corresponding one of the plurality ofelectrodes 111. In some embodiments, each encircling frame member 410differs from the single encircling strip disposable therapy strips 315in that no adhesive is used to hold the electrodes against the eyelidsof the patient; rather, the elastic side members 420 wrap around thehead of the patient to snugly hold the electrodes 111 against the skinof the patient around the patient's eyes. The absence of adhesive is anadvantage in removing the electrodes from the patient as compared to,for example, removing two single encircling strip disposable therapystrips 315 of a system 301. The absence of adhesive is also an advantagefor patients who may be allergic or sensitive to the adhesive. The othervarious reference numbers in FIG. 4A are as described above for FIG. 3A.

FIG. 4B is a schematic back-side-view diagram of an electrode-containingeye-goggle-frame 402 having two face-conforming eye-encircling strips412, according to some embodiments of the present invention.

FIG. 4C is a schematic top-side-view diagram of eye-goggle-frame 402having two face-conforming encircling strips 410, according to someembodiments of the present invention. In some embodiments,eye-goggle-frame 402 includes a stiff two-part frame member 433 havingan elastic bridge connector 414 flexibly and stretchily holding the twoparts to one another while providing the stretch capability to vary thedistance between to match the eyes of the patient. In some embodiments,each face-conforming eye-encircling strip 412 is positioned on aflexible compressible elastic extension 431 that extends backward(toward the patient's face) from a corresponding base 432 that isattached to the two-part frame member 433. The flexible compressibleelastic extension 431 allows each eye-encircling strip 412 to betterconform to the patient's face. In some embodiments, a cable 114(connecting to, or extending as, electrical wiring withinelectrode-containing eye-goggle-frame 402 to connect to the electrodes111) extends from one side or both sides of two-part frame member 433,and conducts electrical stimulation and/or sensing signals between anexternal controller (not shown here) and the electrodes 111. In someembodiments, each eye-encircling strip 412 is more flexible thanencircling frame member 410, and again differs from the singleencircling strip disposable therapy strips 315 in that no adhesive isused to hold the electrodes against the eyelids of the patient; rather,the elastic side members 420 wrap around the head of the patient tosnugly hold the electrodes 111 against the skin of the patient aroundthe patient's eyes. The other various reference numbers in FIGS. 4B and4C are as described above for FIG. 4A.

FIG. 5A is a schematic exploded top-side-view diagram of aneye-goggle-frame 560 having two yet-to-be-attached disposable adhesiveeye-encircling strips 511, according to some embodiments of the presentinvention. In some embodiments, the adhesive on the removable andreplaceable eye-encircling strips 511 is on the frame side (not on theside that touches the patient's face) and adheres eye-encircling strips511 to surface 512 on the elastic cups 531. In some embodiments,electrical connectors 541 on the strips 511 electrically connect tomatching cup-side connectors 542 on surface 512 of the flexiblecompressible elastic extension 531. As with the device of FIGS. 4B and4C, in some embodiments, eye-goggle-frame 561 includes a stiff two-partframe member 533 having an elastic bridge connector 534 flexibly andstretchily holding the two parts of frame member 533 to one anotherwhile providing the stretch capability to vary the eye-to-eye distancebetween the two parts to match the eyes of the patient. In otherembodiments, frame 533 is a single stiff piece (omitting elastic bridgeconnector 534) and the flexible compressible elastic extensions 531provide the lateral eye-to-eye distance compensation. In someembodiments, each face-conforming eye-encircling strip-receiving surface512 is positioned on a flexible compressible elastic extension 531 thatextends backward (toward the patient's face) from a corresponding base532 that is attached to the frame member 533. The flexible compressibleelastic extension 531 allows each eye-encircling strip 511 (which isadhered to flexible surface 512) to better conform to the patient'sface. In some embodiments, each eye-encircling strip 511 includes adouble-sided pressure-sensitive-adhesive-coated foam layer 518, adheredon one of its faces to a hypo-allergenic substrate 517 on which aredeposited a plurality of electrodes 111 each individually electricallyconnected by a conductor (also deposited on substrate 517) to a separatecorresponding contact on electrical connector 541. In some embodiments,a first peel-away protective layer on the frame side of double-sidedpressure-sensitive-adhesive-coated foam layer 518 is removed so thateye-encircling strip 511 can be stuck (adhered) to strip-receivingsurface 512. In some embodiments, a small glob of electricallyconductive gel is deposited on each electrode 111, and a secondpeel-away adhesive-coated protective layer is provided on thepatient-skin side of eye-encircling strip 511 that covers electrodes 111and the gel, wherein the second peel-away protective layer keeps eachglob of gel on its corresponding electrode 111 and separated fromneighboring electrodes until the second peel-away protective layer isremoved immediately prior to use. In some embodiments, a vibration motorsuch as vibrator 121 of FIG. 1D is incorporated in disposable strip 511.In some embodiments, one or more LEDs 122 (such as those of FIG. 1D) areincorporated in disposable strip 511. In some embodiments, a vibrationmotor such as vibrator 121 of FIG. 1D is instead incorporated ineye-goggle-frame 560 rather than being part of the disposable strip 511.In some embodiments, one or more LEDs 122 (such as those of FIG. 1D) areinstead incorporated in eye-goggle-frame 560 rather than being part ofthe disposable strip 511.

In some embodiments, a controller 161 (e.g., a microprocessor(optionally including an RF (radio-frequency) transceiver thatcommunicates with a remote PC (personal computer), tablet, laptop or thelike) and battery) is mounted to, or is built-in and part of, one sideor both sides of two-part frame member 533, and conducts electricalstimulation and/or sensing signals between an external controller (notshown here) and the electrodes 111. In some embodiments, eacheye-encircling strip 511 and its mounting surface 512 is more flexiblethan encircling frame member 410 of FIG. 4A, and again differs from thesingle encircling strip disposable therapy strips 315 in that noadhesive is used to hold the electrodes against the eyelids of thepatient; rather, in some embodiments, an elastic band (not shown here,but similar to band 662 of FIG. 6A) wraps around the head of the patientto snugly hold the electrodes 111 against the skin of the patient aroundthe patient's eyes (e.g., on the upper and lower eyelids, and/or on thesupraorbital bone (the supraorbital foramen of the frontal bone of theskull) and/or infraorbital bone (the front of the zygomatic bone and/ormaxilla)).

FIG. 5B is a schematic assembled top-side-view diagram of an assembledeye-goggle-frame 562 having two disposable adhesive eye encirclingstrips 515, according to some embodiments of the present invention. Insome embodiments, the two disposable adhesive eye encircling strips 515are removably adhered to the mounting surfaces 512 of eye-goggle-frame561 and the electrical contacts 541 and 542 are connected to oneanother. Note that reference number 515 refers to each eye-encirclingstrip 511 after it is adhered to and electrically connected toeye-goggle-frame 561, and reference number 562 refers to the combinationof eye-goggle-frame 561 after the two eye-encircling strips 511 areadhered to and electrically connected to eye-goggle-frame 561. In someembodiments, a small amount of electrically conductive gel is depositedon each electrode 111. In some embodiments, a through-hole opening allthe way through eye-goggle-frame 561 is left in front of each of thepatient's eyes (wherein one of the adhesive eye encircling strips 515surrounds each of these through-hole openings) such that the patient cansee the surrounding environment during the therapy session, in order toreduce claustrophobia, fear or other stress conditions for the patient.In other embodiments, a translucent or opaque covering is provided inorder the encourage the patient to minimize eye movement so that thesequence of therapy stimulation pulses continue to stimulate the desiredtissue volumes throughout the therapy session. In some embodiments, oneor both of adhesive eye encircling strips 515 further include one ormore LEDs (such as, for example, LEDs 122 of FIG. 1D) that provide theoptical indicator function described above, and/or one or more vibrationunits (such as, for example, vibration units 121 of FIG. 1D) thatprovide the tactile-feedback function described above. The other variousreference numbers in FIGS. 5A and 5B are as described above for FIG. 4A.

FIG. 6A is a schematic front-view diagram of a system 601 that includestwo single semi-encircling disposable therapy strips 615 that togetherwith controller 661 and its elastic head strap 662 forming a system 601,according to some embodiments of the present invention. In someembodiments, system 601 includes one or more electrodes 641, which areplaced in contact with skin on the neck of patient 99, and attached tothe main device (controller 661) by conductor (e.g., in someembodiments, wire) 642. In some embodiments, a nose-pad and pad-arm unit651 is provided to support the controller 661 on the forehead of patient99 over the patient's eyes 98. In some embodiments, the therapeuticelectrical-stimulation pulses are applied in a sequence (one at a time)to the electrodes 111 on therapy strips 615 surrounding each eye,wherein the return path (i.e., the ground signal) is provided throughelectrodes 641 (in some embodiments, one or more electrodes 641 isadhesively a coupled to the neck of patient 99; e.g., one to each sideof the neck as shown). In some embodiments, uniphasic signals areapplied to the eye electrodes (either all positive voltages relative toground electrode(s) 614, or all negative relative to ground electrode(s)614) in order to accumulate the desired ionic molecules in or near theretinas of the patient). In other embodiments, balanced biphasic signalsare applied to the eye electrodes (alternating with some positivevoltages and some negative voltages relative to ground electrode(s) 614,or by applying differential signals to selected pairs of electrodes 111without using a ground signal to ground electrode(s) 614, and in somesuch embodiments, ground electrode(s) 614 are omitted) in order toprevent accumulation of undesired ionic molecules in or near the retinasof the patient). In other embodiments, uniphasic or biphasic signals areapplied between pairs of electrodes 111 wherein the current is appliedbetween one electrode 111 near one eye (on, say, the left-handdisposable therapy strip 615) and one electrode 111 near the other eye(on, say, the right-hand disposable therapy strip 615). In otherembodiments, uniphasic or biphasic signals are applied between pairs ofelectrodes 111 wherein the current is applied between one electrode 111and another electrode 111 on the same disposable therapy strip 615.

FIG. 6B is a plan-view diagram of a disposable set 660 of electrodesincluding a single semi-encircling strip disposable therapy strip 615and a single “ground” electrode 641, according to some embodiments ofthe present invention. In some embodiments, two such sets 660 ofelectrodes are adhered to the patient 99 in the desired positions; thena controller unit 661 (e.g., mounted to a headband such as shown in FIG.6A, or mounted to eyeglasses (such as in FIG. 4A, or mounted to aneck-mounted or other suitably positioned controller)) worn by patient99 is electrically (and/or optically, in the case where optical fiberscouple light from LEDs in the controller unit to emission points ontherapy strip 615) connected to each unit of the sets 660 of electrodes.In some embodiments, electrode 641 is connected to the device byconductor cable 642. Some embodiments include a tab or connector unitlocated between parts of the controller 661 to allow for modularassembly and replacement of parts of the device.

FIG. 7 is a schematic block diagram of a therapy system 700 including acontroller 701 and electrodes 715, according to some embodiments of thepresent invention. In some embodiments, therapy system 700 includes basestation 790, controller 701, FLASH drive 796, disposable electrodes 715,and (as needed) disposable ground patches, conductive gel and cleaningwipes. In some embodiments, base station 790 is a device, such as alaptop personal computer (PC), tablet computer, desktop computer or thelike, for selecting parameters, monitoring performance, data collectionand storage and communication with the control unit (controller 701). Insome embodiments, controller 701 is a control unit that contains theelectronics that deliver current to the electrode contacts on the eye.In some embodiments, the electrode contacts are part of a disposablestrip, goggles or an individual probe or the like. In some embodiments,FLASH drive 796 is a USB “thumb drive” that includes encrypted data andprogram code to provide a fixed number of prepaid patient therapies,wherein each time a successful therapy is completed one therapy unit isdeducted from the flash drive. In some embodiments, FLASH drive 796 is aUSB “thumb drive” that includes encrypted data and program code toprovide prescriptions for specific patient therapies, wherein each timea successful therapy is completed one therapy unit is deducted from theflash drive. In some embodiments, once all available therapy unitsessions are completed, the FLASH drive 796 can be discarded and a newprepaid flash drive is used. In other embodiments, the FLASH drive 796is also used to gather and record session data and parameters that canbe later analyzed to determine long-term effectiveness of variousdifferent therapy variations, so once all available therapy unitsessions are completed, the FLASH drive 796 is returned to the analysisfacility and in exchange for the data and a per-therapy-session fee, anew prepaid flash drive is sent out to the treatment facility. In someembodiments, the patient identification data is anonymized and encryptedfor patient privacy and/or legal requirements, while keeping eachsession with enough information to analyze what works and what does notwork. In some embodiments, disposable electrodes 715 include a pluralityof electrode contacts in the form of an adhesive strip, disposablehandheld probe tip or goggle, that includes, for example, six to twelvecontacts (or other suitable number), split with some on the upper eyelidportion and others on the lower eyelid portion. In some embodiments, akit is provided wherein, in addition to the above-mentioned disposableelectrodes 715 (contact strips), one or more handheld probe tips, and/orgoggles and the flash drive, the kit also includes such items asdisposable ground patches, conductive gel and cleaning wipes.

In some embodiments, controller 701 includes a microprocessor 711, apower system (such as a battery, ultra-capacitor or the like) 712 thatsupplies electrical power to the rest of the controller 701, acurrent-source 713 that is controlled by microprocessor 711 based onsignals from current and impedance sensor 719, an electrode sequencer714 that selects, for example, which one of six possible electrodes towhich to send the electrical pulse signal at any moment in time, ascontrolled by microprocessor 711, and these pulses are sent throughelectrode connector 716 to the set of electrodes 715. In someembodiments, the set of disposable electrodes 715 also includes one ormore LEDs (e.g., such as 122 of FIG. 1D) embedded in or on the strip,wherein these LEDs are driven by electrical signals sent throughconnector 716 and provide a status and patient-feedback function to tellthe medical-professional person and/or the patient that the system isfunctioning and active. In other embodiments, one or more status LEDs717 are located in the controller 701 and emit light to indicate statusdirectly from controller 701, and/or through optical fibers 726 or thelike embedded in or on the strip to emission points on the electrodestrip, wherein these LEDs 717 are driven by electrical signals frommicroprocessor 711 and, as described above, provide a status andpatient-feedback function to tell the medical-professional person and/orthe patient that the system is functioning and active. In someembodiments, a wireless communications device 718 (such as Bluetooth®,NFC, infrared optical communications, or the like) provides one-way ortwo-way communications to a base station 790. In some embodiments, basestation 790, based on a prepaid therapy authorization from, e.g., FLASHdrive 796, transmits 791 programming information specific for theparticular patient, wherein the authorization optionally includesauthorization based on a fee having been paid, as well aspatient-specific therapy control information that has been customizedfor the particular identified patient to be treated this session basedon a treatment regimen prescribed by an eye doctor or the like. In someembodiments, session parameters are communicated 792 back to the basestation (with parameters such as the actual number, polarity, sequenceand strength of pulses, the measured impedance and/or current, indicatedpatient discomfort, and the like). In some embodiments, system 701includes a patient-activatable switch (e.g., on system 701 or via aseparate handheld switch that is wirelessly or in wired communicationwith system 701) that the patient is instructed to press if and when thepatient feels discomfort or concern, and upon activation of that switch,electrical output from system 701 or even the entire system 701 isimmediately shut off, and/or the timing of the activation of the switchby the patient is recorded and transmitted in the communication 792 ofparameters from the session. Thus, this feedback from the patientherself or himself, in some embodiments, is used to fully shut down thedevice (for patient comfort and peace-of-mind, as well as a furtherenhancement to patient safety just in case the current source 713 has afault and is sending too much current), and is then correlated to aparticular time or other aspect of the treatment to allow design ofbetter therapy sessions in the future, and/or can be used to immediatelyterminate the session (wherein microcontroller 711 will immediatelychange all connections to “OFF” (or high impedance) to block any furthercurrent to the patient, and/or the entire system 701 is then (i.e.,after storing the timestamp of the switch press by the patient) shutdown and disconnected from power source (e.g., battery) 712. In someembodiments, system 701 and/or base station 790 include an audio-outputunit 720 that provides a sound (beep, chime, ding, or the like)associated with therapy session status, to indicate, e.g., “ON/sessionstarting,” in therapy, an alert as to insufficient or inappropriatetreatment, and “OFF/session ending.”

In some embodiments, system 700 is a software-driven system thatprovides programmability of all parameters including frequency,waveform, current level, duration of therapy and number of “cycles”around the eye (wherein, in some embodiments, one cycle is theindependent activation of each of the six to twelve electrode contacts).In some embodiments, these parameters are programmed duringmanufacturing, while in other embodiments, the parameters are programmedin the field by the clinician or a company representative. In someembodiments, modifications to the programming parameters and/or software(e.g., as customized by the prescription for the treatment protocolprovided by a licensed medical professional for a specific identifiedpatient) are stored in a plug-in storage device 796 (such as a USB FLASHstorage device or the like) and the parameters and/or program and loaded(by plugging-in device 796) into base station 790 (and then transmitted791 (e.g., wirelessly or by wired connection) to system 701 to be storedin the memory of microprocessor 711). In other embodiments, plug-instorage device 796 is plugged directly into system 701 to load and storethe parameters and/or program into the memory of microprocessor 711 (insome such embodiments, the base station 790 is omitted, while in otherembodiments, base station 790 is retained to provide thetechnician/medical professional with status of each session in realtime). In some embodiments, base station 790 is used to provide thetechnician/medical professional with status of each session of aplurality of simultaneous patient sessions in real time (e.g., in someembodiments, a laptop computer used as base station 790 is programmed toprovide a split-screen progress monitor (e.g., wherein the displayscreen is split into, e.g., quadrants if up to four patients weresimultaneously treated) for a plurality of treatment sessions for eachof a plurality of patients). In some embodiments, the software may alsobe modified remotely using the wireless connection to the base station790. In some embodiments, a prescription for a treatment session (theprotocol, parameters and the like for controlling current amount, pulseduration, inter-pulse spacing and how many pulses are to be sent and thelike) for each individual patient is prepared and checked by a licensedprofessional, and this prescription is downloaded and/or stored in basestation 790, or into USB device 796 along with the prepaid activationcode to enable only authorized treatments for specific patients. In someembodiments, the software in base station 790 and/or the software insystem 701 verifies the match between a specific patient's prescriptionassociated with a specific identified patient and patient-identificationinformation of the specific identified patient in order to verify thatthe correct prescription is used for that patient.

Some embodiments include a large memory in the system 701 and/or in thebase station to capture and record all pertinent patient and clinicdata, including the treatment protocol such as the number of pulsesapplied to each electrode, the amount of current, and all other relevantparameters of what the treatment session involved (including, forexample, whether an actual or sham treatment session was provided to theparticular patient). In some embodiments, the recorded data are storedin a permanent-memory portion of USB storage device 796 (e.g., using aportion of memory that allows only a single write operation that may befollowed by many read operations, in order that the data are permanentlystored and later available). In some embodiments, these data arecollected remotely and summarized by company and/or clinic personnel. Insome embodiments, data is summarized to provide comparisons betweenpatients and clinics and may be used in research. Over time, this datawill allow the company or analysis facility to optimize the design andthe clinical protocol, thus improving outcomes.

Some embodiments provide greater current-drive capacity via currentsource 713, as well as better current and impedance measurements viasensor unit 719. This allows the system 701 to deliver greater, andmore-carefully controlled, current levels that overcome any unexpectedhigher impedance levels. In some embodiments, apparatus 700 has agovernor (e.g., current controller) to prevent delivery of more than 350microamps (μA) to the patient during therapy. In some embodiments, basestation 790 and/or system 701 may be activated only via an appropriatelyencoded message from flash drive 796, or via an authentic encrypted code(e.g., in some embodiments, received from a company website on theinternet) that enables the laptop to signal, via WI-FI in someembodiments, the microstimulation controller 711 to conduct the therapysession for a particular identified patient. In some embodiments, themicrostimulation controller 711 and system 701 is implemented on thegoggle (e.g., unit 161 in FIG. 5A), and apparatus 701 may be activatedvia a flash drive 796 plugged into system 701 or by any other suitabletype of connection (such as a USB cable to base station 790).

Some embodiments provide automatic adjustment to changes in impedance.As impedance changes during treatment, from contact to contact and fromeye to eye, the control unit 701 will automatically adjust to maintain aconsistent current level. This improves performance and outcomes. Thetreatment has been automated to minimize clinician involvement. Thesystem 700 automatically manages the therapy to ensure uniform andrepeatable results.

In some embodiments, the control unit 701 is designed to fit and connectnicely on the left and right ground patches (e.g., 641 of FIG. 6A). Thiseliminates the potential of losing signal to the left and right set ofcontacts due to patient movement during therapy. The small size of thecontrol unit reduces clutter, improves patient comfort, and improvesdevice consistency and compliance.

In some embodiments, the control unit is designed to be tamper proof(both physically and electronically), and to provide encryption on theprogramming and the sensed parameters to prevent hacking.

In some embodiments, the base station 790 communicates with the controlunit 701 via a wireless connection eliminating the need to tether thepatient to the base station. This improves compliance and makes thesetup and therapy session easier to manage.

In some embodiments, the base station can communicate with multiplecontrol units at one time reducing the number of base stations required,therefore reducing set-up time and the clinician's time to managemultiple patients.

In some embodiments, multiple levels of protection help ensure that theelectrical current delivered to the contacts cannot exceed theprogrammed current. The design ensures that an unsafe level of currentcannot be achieved even if the output was shorted (zero impedance). Insome embodiments, the control unit 701 is powered by a smalldirect-current (DC) button cell and is not connected to the base stationduring therapy, reducing or eliminating the possibility of injury to thepatient.

In some embodiments, the low cost of the design allows most or all ofthe system to be single-use and disposable.

In some embodiments, the base station can communicate with a device suchas a goggle device and or strips partially or completely encircling theupper and or lower eyelids, as well as other body parts.

FIG. 8 is a schematic block diagram of a therapy system 800 including acontroller 161 and a plurality of light sensors 811 mounted to aneyeglass frame or goggle-type fixture, according to some embodiments ofthe present invention. The other various reference numbers in FIG. 8 areas described above for FIG. 4A. In some embodiments, the plurality oflight sensors 811 are used to sense the amount and/or direction of theambient light in the room where the therapy is provided, and these dataare recorded during some or all sessions, in order to determine whetheror not ambient room light during the session makes any difference to theefficacy or effectiveness of treatment (i.e., this provides oneadditional parameter that is recorded, just in case the ambient lightduring the therapy session affects outcome and/or whether the patientfeels less anxiety or boredom during therapy under differing ambientlight conditions).

In some embodiments, the present invention includes combinations of twoor more features that are individually and/or collectively shown anddescribed above in FIG. 1A through FIG. 8. One non-limiting example ofsuch a combination is to include one or more vibrators, and/or one ormore LEDs and/or one or more electrode contact points in the goggle-typefixture of FIG. 8. In some other embodiments, the present inventionprovides subcombinations that include most features of the variousembodiments, but omit one or more features that are individually shownand described above in FIG. 1A through FIG. 8.

Some embodiments of the present invention include a disposable therapyappliance that preferably includes a curved linear strip,semi-encircling strip, or encircling strip of material containing aplurality of electrodes for applying the microcurrent therapy, andoptionally one or more sensors and/or other transducers. In someembodiments, the linear, semi-encircling, or encircling strip ofmaterial is positioned to place electrodes on the upper eye lid and thelower eye lid. In some embodiments, the curved linear, semi-encircling,or encircling strip of material includes a mild adhesive to make thestrip adhere to the skin, and/or includes a conductive gel at theelectrode contact points. Within or on the linear, semi-encircling, orencircling strip are electrodes spaced at specific points that are wiredindividually and separately to a controller apparatus that generates theprescribed microcurrent in a sequence to the plurality of electrodepoints on the material. In some embodiments, themicrocurrent-stimulation controller apparatus to which the disposabletherapy appliance is connected also contains a software system that isprogrammed to sequence the therapy to the various electrode points onthe material, and to also detect electrical impendence from the patient,and thereby provide feedback to the controller apparatus toautomatically adjust the level of microcurrent simulation, in order todeliver the amount of stimulation originally pre-selected for thattreatment session by the clinician to achieve improved/optimum therapy.

In some embodiments, the disposable therapy appliance includes one ormore “light-delivery” filaments threaded through or LEDs embedded in oron the strip material to convey a low level of light signal, indicatingto the patient that the appliance/strip is functioning as intended. Thislow level of light signal is of a selected intensity and a selectedspectrum chosen to penetrate the patient's closed eyelid and be receivedby those photoreceptor cells functioning in the back of the retina. Insome embodiments, the light signal will resemble a dull flash orpulsating light, and may be either a white light or a specially coloredlight (such as red or green).

In some embodiments, the disposable therapy appliance includes avibrating filament threaded through the strip or vibrator embedded in oron the strip material or simply connected to the strip, to convey agentle level of vibration as the microcurrent stimulation therapy isbeing applied. Again, in some embodiments, this provides the function ofconveying to the patient that the stimulation is being delivered forthose instances where the electrostimulation of the microcurrent,itself, is simply unfelt by the patient. The benefit of this is that thepatient can feel that the system is working, and the patient will thenbe more willing to sit still and complete the full treatment session,versus a session where the patient has no marker to indicate thatanything is happening.

In some embodiments, the disposable therapy appliance is positioned andaffixed to the patient by the attending physician or clinician in theclinic. The patient's eyelid is cleaned with sterile solution containedin a wipe or similar material. The clinician, using sterile surgicalgloves, then opens the packet containing the disposable therapyappliance(s). In some embodiments, the disposable therapy strips have acrack-open, peel-off backing that is removed just prior to user. In someembodiments, the clinician then applies the strip(s) in the followingmanner:

A) For embodiments implemented as individual curved linear strips: afirst strip is placed on the closed upper eyelid, below the eyebrow,across or beneath the bone of the upper eye orbit cavity. With the eyeremaining closed, a second strip is then applied under the eye, alongthe bone of the lower orbit. If the patient's other eye is to bestimulated, then the individual strips for the second eye are preparedin the same fashion. Then, the strips are connected to the micro-currentstimulation controller apparatus to initiate therapy.

B) For embodiments implemented as semi-circle strip: the top of thestrip is placed on the closed eyelid, below the eyebrow, across the boneof the upper eye orbit cavity. With the eye remaining closed, the lowerpart of the strip-semicircle is then applied under the eye, along thebone of the lower orbit. If a second eye is to be stimulated, then thesecond eye is prepared in the same fashion with a second semi-circlestrip. Then the strip(s) is/are connected to the micro-currentstimulation controller apparatus to initiate therapy.

C) For embodiments implemented as circular strip: the top of thecircular strip is placed on the closed eyelid, below the eyebrow, acrossthe bone of the upper eye orbit cavity. With the eye remaining closed,the lower part of the circular strip is applied under the eye, along thebone of the lower orbit. If the patient's other eye is to be stimulated,then the second eye is prepared in the same fashion with a secondcircular strip. Then the strip or strips are connected to themicro-current stimulation controller apparatus to initiate therapy.

In some embodiments, when the therapy is finished, a beeper sounds, alight turns on or flashes, and/or other indication of completion isprovided. The clinician then disconnects the strips from themicro-current stimulation controller apparatus generating themicro-current stimulation. The clinician then gently peels back thestrips (from whatever configuration is used). The strips will bedisposed of in accordance with company instructions as guided by anygovernment directives. The patient's eye is re-cleansed with a sterilewipe or pad.

Advantages of the new technology of the present invention'smicro-current stimulation curved linear strip, semi-encircling strip, orencircling strip include:

a. providing a novel electrode appliance for providing microcurrentstimulation therapy to a body part to combat chronic pain, injury, ordisease in that body part;

b. providing a novel electrode appliance for treating various diseases,including macular degeneration and retinitis pigmentosa;

c. providing an electrode appliance that delivers microcurrentstimulation therapy via a strip, semi-circle or circle of materialcontaining a plurality of electrodes that are wired individuallyseparately to the micro-current stimulation controller apparatus and arepositioned to predetermined spaced-apart locations on the upper and/orlower eye lid with an adhesive material;

d. providing sensors to monitor the current supplied to the variouspoints in the material and adjust the current based upon the degree ofimpedance of the patient's tissue;

e. providing curved linear strips, semi-encircling strips, or encirclingstrips or other shaped strips, semicircles or circles of materialcontaining various numbers of electrodes that are disposable after eachtreatment session. In some embodiments, the invention is packaged inclean or sterile packaging, depending upon the requirements, in abarrier or contamination-proof package. The disposability reduces therisk of cross contamination between patients and eliminates the need tosterilize or clean a hand-held probe conventionally used by clinicalprofessionals to treat patients.

f. optionally including one or more light filaments that can signal tothe patient during the therapy session that the proper level of therapyis being delivered to the patient and that they are not experiencingundue impedance.

g. incorporating a safety feature by separately wiring each electrode orsensor to the treatment device that provides the electrical stimulation.Such a design prevents more than one electrode delivering the therapysimultaneously and potentially injuring the patient;

h. that the stimulation is not carried simultaneously over the entiresurface of the treatment strip or semi-circle or circle but isconcentrated at specific individual spaced-apart sites;

i. determining specific areas of stimulation by the software program ofthe apparatus connected to the microcurrent strip, circle orsemi-circle. The microcurrent strip, circle or semi-circle hasspecifically located points within the material that can deliver timedor sequenced specific stimulation to different points along thematerial, in a pre-set sequence, for a varied or pre-set time, at anindividual point of contact, or at two or more points of individualcontact, with preset stimulation levels, as opposed to a large pad whichoffers blanket stimulation over the entire surface area of the pad.

j. enabling the physician, using the therapy appliance and its treatmentmethodology, to target stimulation to a particular treatment point (insome embodiments, as small as 1-2 millimeters, or as large as 5-10millimeters), which improves treatment efficacy since a higher currentdose cannot be tolerated by the body at a small pinpoint of delivery, orbe effective if delivered over a larger surface area, such as by astandard gel pad. Further, this stimulation can be delivered to aspecifically designed and tolerated treatment point within a timedsequence and then on to another in a pre-set pattern designed tooptimize treatment results for patients.

Details in some embodiments of the disposable adhesive appliancesinclude one or more of the following:

a) Application to upper, and/or lower eye, as well as other body parts.

b) Microstimulation curved linear strips, semi-encircling strips, orencircling strips is disposable packaged sterile or clean

c) Microstimulation curved linear strips, semi-encircling strips, orencircling strips is gel coated and with perimeter adhesive

d) Microstimulation curved linear strips, semi-encircling strips, orencircling strips contains unique contact points that:

-   -   i. have between 2-10 contact points on each curved linear strip;    -   ii. have between 2-20 contact points on semi-encircling strips,        or encircling strips;    -   iii. does not stimulate entire set of electrodes on a pair of        curved linear strips, semi-encircling strips, or encircling        strips; only specific points selected within the stimulation        program determined by physician and programmed into the        apparatus;    -   iv. Contact points can be activated individually (one-at-a-time)        or multiple points at a time; meaning that in some embodiments,        only one contact point can stimulate at a time per eye, or body        part; OR in other embodiments, two or more contact points may        stimulate simultaneously, determined by the program mode        selected on the apparatus. However, the entirety of the strip or        semi-circle or circle is not active with stimulation at any one        given point in time;    -   v. Contact points can be sequenced, in a pattern that is pre-set        and determined by the program of the apparatus delivering the        stimulation;    -   vi. Contact points are capable of receiving varied stimulation        levels as determined by the apparatus, meaning that the        stimulation level delivered through the various contact points        can vary and be increased or decreased throughout the course of        the treatment program selected either as determined by the        apparatus or by the physician.

e) Safety Element: Strips rely on a safety governor built in to thedevice (apparatus) so one point cannot deliver more than 350 mA current.Strips have a built-in sensor to monitor the stimulation level deliveredin order to improve treatment performance. In some embodiments, thesensor also gauges impedance at the site of stimulation and adjustscurrent through a feedback loop.

f) Strips contain a light filament built in to indicate stimulationdelivery.

g) Strips contain a vibration element designed to indicate stimulationdelivery.

h) Strips contain a connection element to primary device.

In some embodiments, the present invention provides an apparatus thatincludes: a disposable therapy appliance, wherein the disposable therapyappliance includes: a strip of material containing a plurality ofelectrodes configured to apply microcurrent stimulation therapy to apatient, wherein each electrode is no larger than 25 mm², and whereinthe strip is shaped to be positioned to place electrodes on an uppereyelid and a lower eyelid of a the patient's skin, and wherein each oneof the plurality of electrodes is configured to be individuallyactivated at a time for microcurrent stimulation without activation ofany other ones of the plurality of electrodes during that time.

In some embodiments of the apparatus, the strip of material includes anadhesive suitable to adhere the strip adhere to the skin.

In some embodiments of the apparatus, the strip of material includes anamount of conductive gel on a skin-contact point of each one of theplurality of electrodes, and the apparatus further includes a removableprotective layer that separately encloses each amount of conductive gelsuch that the amounts of conductive gel do not touch each other when thestrip is applied to the patient's skin.

Some embodiments of the apparatus further include amicrocurrent-stimulation controller, wherein the electrodes are spacedat predetermined location points along the strip of material, and arewired individually and separately to the microcurrent-stimulationcontroller, and wherein the microcurrent-stimulation controllergenerates a prescribed microcurrent delivered to each electrode of theplurality of electrodes in a temporal sequence. In some suchembodiments, the microcurrent-stimulation controller apparatus containsa software system that is programmed to sequence the therapy to theplurality of electrodes, and to also detect electrical impedance betweenthe electrodes and the patient, and thereby provide feedback to thecontroller to automatically adjust the level of microcurrent simulation,in order to deliver the amount of stimulation originally pre-selectedfor that treatment session by the clinician to achieve improved/optimumtherapy. In some embodiments, the microcurrent-stimulation controllerapparatus includes a current controller circuit operative to control anamount of current; the microcurrent-stimulation controller apparatusincludes a current sensing circuit operative to provide a first feedbacksignal indicative of the amount of current delivered to one of theplurality of electrodes; and the software system in themicrocurrent-stimulation controller apparatus adjusts the currentcontroller circuit based on the first feedback signal and on the set ofparameters selected for the patient. In some embodiments, themicrocurrent-stimulation controller apparatus includes apatient-activatable switch, and wherein the microcurrent-stimulationcontroller apparatus is configured to stop therapy upon activation ofthe switch. In some embodiments, the microcurrent-stimulation controllerapparatus includes a patient-activatable switch, and wherein themicrocurrent-stimulation controller apparatus is configured to record atimestamp associated with activation of the switch. In some embodiments,the microcurrent-stimulation controller apparatus is configured tovisibly show status of the treatment session. In some embodiments, themicrocurrent-stimulation controller apparatus is configured to capturedata parameters of the treatment session and to transmit the captureddata to a base station for analysis to refine later treatment sessionsand to confirm the apparatus is working properly and being administeredproperly, and to ensure consistency of results. In some embodiments, themicrocurrent-stimulation controller apparatus is configured to adjustprotocol for a treatment session in a clinic via the software systembased on a received WIFI signal. In some embodiments, themicrocurrent-stimulation controller apparatus is configured to adjustprotocol for a treatment session in a clinic via the software systembased on a signal received from a remote system via the internet. Insome embodiments, the microcurrent-stimulation controller apparatus isconfigured to adjust protocol for a treatment session based on datareceived from a USB-connected storage device directly connected to themicrocurrent-stimulation controller apparatus. In some embodiments, themicrocurrent-stimulation controller apparatus is configured to adjustprotocol for a treatment session based on data wirelessly received froma base station having a USB-connected storage device directly connectedto the base station.

Some embodiments of the apparatus further include a vibrator connectedto the strip to convey a gentle level of vibration as the microcurrentstimulation therapy is being applied.

Some embodiments of the apparatus further include at least one lightemitter device on the strip. In some such embodiments, the strip istransparent or translucent such that light from the at least one lightemitter device is visible to both the patient and to an outsideobserver.

Some embodiments of the apparatus further include a plurality of lightemitter devices on the strip, wherein each respective one of theplurality of electrodes has an associated one of the plurality of lightemitter devices in a vicinity of the respective electrode; and amicrocurrent-stimulation controller, wherein the electrodes spaced atpredetermined location points along the strip of material, and are wiredindividually and separately to the microcurrent-stimulation controller,wherein the microcurrent-stimulation controller generates a prescribedmicrocurrent pulse delivered to each electrode of the plurality ofelectrodes in a temporal sequence, and wherein themicrocurrent-stimulation controller activates the respective associatedone of the plurality of light emitter devices during the deliveredmicrocurrent pulse to the respective electrode. In some suchembodiments, the microcurrent-stimulation controller is configured toreceive activation data from a USB storage device, and wherein theactivation data is encrypted, and wherein the encrypted activation datais required to be received by the microcurrent-stimulation controllerbefore a microcurrent stimulation therapy session is initiated.

In some embodiments of the apparatus, the strip of material includes anadhesive suitable to adhere the strip to a goggle device; and theapparatus further includes the goggle device, wherein the goggle deviceis shaped to hold the plurality of electrodes against the patient's skinwithout any adhesive touching the patient's skin. In some suchembodiments, the apparatus further includes a vibrator connected to thegoggle device to convey a gentle level of vibration as the microcurrentstimulation therapy is being applied.

In some embodiments, the present invention provides a method thatincludes: providing a disposable strip of material containing aplurality of electrodes configured to apply microcurrent stimulationtherapy to a patient, wherein each electrode is no larger than 25 mm²,and wherein the strip is shaped to be positioned to place electrodes onan upper eyelid and a lower eyelid of the patient's skin, wherein theelectrodes are spaced at predetermined location points along the stripof material, and wherein each one of the plurality of electrodes isconfigured to be individually activated at a time for microcurrentstimulation without activation of any other ones of the plurality ofelectrodes during that time; providing a microcurrent-stimulationcontroller, wherein the electrodes are wired individually and separatelyto the microcurrent-stimulation controller; applying the disposablestrip of material to the patient's skin; generating prescribedmicrocurrent pulses by the microcurrent-stimulation controller; anddelivering the microcurrent pulses to each respective electrode of theplurality of electrodes in a temporal sequence.

In some embodiments of the method, the strip of material includes apressure-sensitive adhesive suitable to adhere the strip adhere to theskin, and wherein the applying the disposable strip of material to thepatient's skin includes contacting the adhesive to the patient's skin.

In some embodiments of the method, the strip of material includes anamount of conductive gel on a skin-contact point of each one of theplurality of electrodes, and a removable protective layer thatseparately encloses each amount of conductive gel such that the amountsof conductive gel do not touch each other when the strip is applied tothe patient's skin.

Some embodiments of the method further include sequencing the therapy tothe plurality of electrodes under software control; detecting electricalimpedance between the electrodes and the patient; and providing feedbackto automatically adjust a level of microcurrent simulation, in order todeliver the amount of stimulation originally pre-selected for thattreatment session to achieve improved and/or optimum therapy.

Some embodiments of the method further include conveying a gentle levelof vibration as the microcurrent stimulation therapy is being applied.

Some embodiments of the method further include emitting light from thestrip. Some embodiments of the method further include emitting lightfrom the rim of a pair of goggles or the frame of a pair of eyeglasses,wherein the goggles hold the strip against the patient's skin, andwherein the light is visible to the patient through the strip.

Some embodiments of the method further include emitting light from aplurality of light-emitting locations on the strip, wherein eachlight-emitting location is in a vicinity of an associated respective oneof the plurality of electrodes; and wherein the emitting light from therespective associated one of the plurality of light-emitting locationsis during the delivering of the microcurrent pulse to the respectiveelectrode. Some embodiments of the method further include emitting lightfrom a plurality of locations on the rim of a pair of goggles or theframe of a pair of eyeglasses, wherein the goggles hold the stripagainst the patient's skin, and wherein the light is visible to thepatient through the strip coming from the plurality of locations.

Some embodiments of the method further include receiving activation datafrom a USB storage device, and wherein the activation data is encrypted,and wherein the encrypted activation data is required to be receivedbefore a microcurrent stimulation therapy session is initiated. In somesuch embodiments, the activation data includes identification of aparticular patient and a prescription that includes parameters thatcontrol a therapy session for that particular patient. In some suchembodiments, the activation data includes payment information for aparticular patient. In some such embodiments, the activation dataincludes payment information for a predetermined number of therapysessions.

Some embodiments of the method further include receiving activation datafrom a USB storage device, and wherein the activation data is notencrypted, and wherein the non-encrypted activation data is required tobe received before a microcurrent stimulation therapy session isinitiated.

In some embodiments of the method, the applying of the disposable stripof material to the patient's skin includes adhering the strip to agoggle device shaped to hold the plurality of electrodes against thepatient's skin without any adhesive touching the patient's skin.

Some embodiments of the method further include conveying a gentle levelof vibration as the microcurrent stimulation therapy is being applied.

In some embodiments, the present invention provides an apparatus thatincludes: a disposable strip of material containing a plurality ofelectrodes configured to apply microcurrent stimulation therapy to apatient, wherein each electrode is no larger than 25 mm², and whereinthe strip is shaped to be positioned to place electrodes on an uppereyelid and a lower eyelid of the patient's skin, wherein the electrodesare spaced at predetermined location points along the strip of material,and wherein each one of the plurality of electrodes is configured to beindividually activated at a time for microcurrent stimulation withoutactivation of any other ones of the plurality of electrodes during thattime; means for applying the disposable strip of material to thepatient's skin such that each one of the plurality of electrodes is inelectrical communication with the patient's skin; means for generatingprescribed microcurrent pulses; and means for delivering themicrocurrent pulses to each respective electrode of the plurality ofelectrodes in a temporal sequence. In some embodiments, the strip ofmaterial includes a pressure-sensitive adhesive suitable to adhere thestrip adhere to the skin, and wherein the means for applying thedisposable strip of material to the patient's skin includes means forcontacting the adhesive to the patient's skin. In some embodiments, thestrip of material includes an amount of conductive gel on a skin-contactpoint of each one of the plurality of electrodes, and removable meansfor separately enclosing each amount of conductive gel such that theamounts of conductive gel do not touch each other when the strip isapplied to the patient's skin. Some embodiments further include

means for sequencing the therapy to the plurality of electrodes undersoftware control; means for detecting electrical impedance between theelectrodes and the patient; and means for providing feedback toautomatically adjust a level of microcurrent simulation, in order todeliver the amount of stimulation originally pre-selected for thattreatment session to achieve improved and/or optimum therapy. Someembodiments further include means for conveying a gentle level ofvibration as the microcurrent stimulation therapy is being applied. Someembodiments further include means for emitting light from the strip.Some embodiments further include means for emitting light from aplurality of light-emitting locations on the strip, wherein eachlight-emitting location is in a vicinity of an associated respective oneof the plurality of electrodes; and wherein the means for emitting lightfrom the respective associated one of the plurality of light-emittinglocations emits light during the delivering of the microcurrent pulse tothe respective electrode.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Although numerous characteristics andadvantages of various embodiments as described herein have been setforth in the foregoing description, together with details of thestructure and function of various embodiments, many other embodimentsand changes to details will be apparent to those of skill in the artupon reviewing the above description. The scope of the invention shouldbe, therefore, determined with reference to the appended claims, alongwith the full scope of equivalents to which such claims are entitled. Inthe appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein,” respectively. Moreover, the terms “first,” “second,” and“third,” etc., are used merely as labels, and are not intended to imposenumerical requirements on their objects.

What is claimed is:
 1. A method comprising: providing a disposable stripof material containing a first plurality of electrodes configured toapply microcurrent stimulation therapy to a patient, wherein the stripof material includes a first elongated portion adapted to place two ormore of the first plurality of electrodes on an outer surface of apatient's upper eyelid and a second elongated portion adapted to placetwo or more of the first plurality of electrodes on the patient's lowereyelid, wherein the first plurality of electrodes are spaced atpredetermined locations along the strip of material, wherein each one ofthe first plurality of electrodes is configured to be individuallyactivated, and wherein each one of the first plurality of electrodes iscoated with an electrically conductive gel; providing amicrocurrent-stimulation controller, wherein the first plurality ofelectrodes are wired individually and separately to themicrocurrent-stimulation controller; applying the disposable strip ofmaterial to the patient's skin; generating prescribed microcurrentpulses by the microcurrent-stimulation controller; and delivering themicrocurrent pulses to each respective electrode of the first pluralityof electrodes in a temporal sequence.
 2. The method of claim 1, whereinthe disposable strip of material includes a pressure-sensitive adhesivesuitable to adhere the strip adhere to the skin, and wherein theapplying the disposable strip of material to the patient's skin includescontacting the pressure-sensitive adhesive to the patient's skin.
 3. Themethod of claim 1, wherein the strip of material includes an amount ofconductive gel on a skin-contact point of each one of the firstplurality of electrodes, and a removable protective layer thatseparately encloses each amount of conductive gel such that the amountsof conductive gel do not touch each other when the strip is applied tothe patient's skin.
 4. The method of claim 1, further comprising:sequencing the therapy to the first plurality of electrodes undersoftware control; detecting electrical impedance between the firstplurality of electrodes and the patient; and providing feedback toautomatically adjust a level of microcurrent simulation, in order todeliver the amount of stimulation originally pre-selected for thattreatment session to achieve improved and/or optimum therapy.
 5. Themethod of claim 1, further comprising: conveying a gentle level ofvibration as the microcurrent stimulation therapy is being applied. 6.The method of claim 1, further comprising: emitting light from a goggle;and using the goggle to press the first plurality of electrodes of thestrip against the patient's skin.
 7. The method of claim 1, furthercomprising: emitting light from a plurality of light-emitting locationson the strip, wherein each light-emitting location is in a vicinity ofan associated respective one of the plurality of electrodes; and whereinthe emitting light from the respective associated one of the pluralityof light-emitting locations is during the delivering of the microcurrentpulse to the respective electrode.
 8. An apparatus comprising: adisposable therapy appliance that includes: a strip of materialcontaining a first plurality of electrodes configured to applymicrocurrent stimulation therapy to a patient, wherein the stripincludes a first elongated portion adapted to place two or more of thefirst plurality of electrodes on an outer surface of a patient's uppereyelid and a second elongated portion adapted to place two or more ofthe first plurality of electrodes on the patient's lower eyelid for atreatment session, wherein each one of the first plurality of electrodesis configured to be individually activated, wherein each one of thefirst plurality of electrodes is coated with an electrically conductivegel and surrounded by an electrically insulating adhesive suitable toadhere the strip to the patient's skin.
 9. The apparatus of claim 8,wherein the strip of material is bifurcated such that the firstelongated portion and the second elongated portion meet one anotherdistal to an outer edge of the patient's eye.
 10. The apparatus of claim8, wherein the disposable therapy appliance includes: a removableprotective layer that separately encloses the conductive gel on eachelectrode such that the conductive gel on different electrodes do nottouch each other when the strip is applied to the patient's skin. 11.The apparatus of claim 8, further comprising: a microcurrent-stimulationcontroller, wherein the first plurality of electrodes are wiredindividually and separately to the microcurrent-stimulation controller,and wherein the microcurrent-stimulation controller generates aprescribed microcurrent delivered to each electrode of the plurality ofelectrodes in a temporal sequence.
 12. The apparatus of claim 11,wherein the microcurrent-stimulation controller apparatus contains asoftware system that is programmed to sequence pulses delivered to thefirst plurality of electrodes for the microcurrent stimulation therapybased on a set of parameters selected for the patient.
 13. The apparatusof claim 11, wherein the microcurrent-stimulation controller apparatusis configured to detect electrical impedance between the electrodes andthe patient, and thereby provide feedback to the controller toautomatically adjust the amount of microcurrent simulation, in order todeliver the amount of microcurrent stimulation originally pre-selectedfor the patient's treatment session by a clinician to achieve improvedtherapy.
 14. The apparatus of claim 11, wherein themicrocurrent-stimulation controller apparatus includes a currentcontroller circuit operative to control an amount of current; whereinthe microcurrent-stimulation controller apparatus includes a currentsensing circuit operative to provide a first feedback signal indicativeof the amount of current delivered to one of the plurality ofelectrodes; and wherein the software system in themicrocurrent-stimulation controller apparatus adjusts the currentcontroller circuit based on the first feedback signal and on the set ofparameters selected for the patient.
 15. The apparatus of claim 11,wherein the microcurrent-stimulation controller apparatus is configuredto adjust protocol for a treatment session based on data wirelesslyreceived from a base station having a USB-connected storage devicedirectly connected to the base station.
 16. The apparatus of claim 8,further comprising a vibrator connected to the strip to convey a gentlelevel of vibration as the microcurrent stimulation therapy is beingapplied.
 17. The apparatus of claim 8, further comprising: a pluralityof light emitter devices on the strip, wherein each respective one ofthe plurality of electrodes has an associated one of the plurality oflight emitter devices in a vicinity of the respective electrode; and amicrocurrent-stimulation controller, wherein the electrodes d are wiredindividually and separately to the microcurrent-stimulation controller,wherein the microcurrent-stimulation controller generates a prescribedmicrocurrent pulse delivered to each electrode of the plurality ofelectrodes in a temporal sequence, and wherein themicrocurrent-stimulation controller activates the respective associatedone of the plurality of light emitter devices during the deliveredmicrocurrent pulse to the respective electrode.
 18. The apparatus ofclaim 8, wherein the strip of material includes an adhesive suitable toadhere the strip to a goggle device; the apparatus further comprising:the goggle device, wherein the goggle device is shaped to hold theplurality of electrodes against the patient's skin without any adhesivetouching the patient's skin.
 19. The apparatus of claim 18, furthercomprising a vibrator connected to the goggle device to convey a gentlelevel of vibration as the microcurrent stimulation therapy is beingapplied.
 20. An apparatus comprising: a disposable strip of materialcontaining a first plurality of electrodes configured to applymicrocurrent stimulation therapy to a patient, wherein the stripincludes a first elongated portion adapted to place two or more of thefirst plurality of electrodes on an outer surface of a patient's uppereyelid and a second elongated portion adapted to place two or more ofthe first plurality of electrodes on the patient's lower eyelid of thepatient's skin, wherein the first plurality of electrodes are spaced atpredetermined locations along the strip of material, and wherein eachone of the first plurality of electrodes is configured to beindividually activated; means for applying the disposable strip ofmaterial to the patient's skin such that each one of the first pluralityof electrodes is in electrical communication with the patient's skin;means for generating prescribed microcurrent pulses; and means fordelivering the microcurrent pulses to each respective electrode of thefirst plurality of electrodes in a temporal sequence.